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Also known as velzatinib - subject to USAN approval, Velzatinib (GSK6042981)
IDRX-42 · 2 trials · 5 indications
PFS is defined as time from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| IDRX-42 (GSK6042981) | EXPERIMENTAL | - |
| Sunitinib | ACTIVE_COMPARATOR | - |
| Dose Escalation (Phase I) | EXPERIMENTAL | Participants should have advanced (metastatic and/or surgically unresectable) GIST, following failure of at least prior imatinib therapy due to progression of GIST. |
| (Phase 1b) Cohort 1 - Participants with GIST progression after first-line imatinib therapy | EXPERIMENTAL | Participants with advanced GIST who have had GIST progression after first-line imatinib only (second line therapy setting) and refused or are ineligible for other standard of care (SOC) therapies. |
| (Phase 1b): Cohort 2 - Participants with GIST progression after 2 or more lines of TKI therapy | EXPERIMENTAL | Participants with metastatic and/or surgically unresectable GIST following progression EITHER after sequential imatinib then sunitinib (third-line therapy setting) OR after imatinib, sunitinib, and then an additional TKI agent (i.e., regorafenib or ripretinib) (fourth-line therapy setting) OR after imatinib, sunitinib, regorafenib, and ripretinib (5th line or greater therapy). |
| (Phase 1b): Cohort 3 - Participants with GIST who are treatment naïve | EXPERIMENTAL | Participants with metastatic and/or surgically unresectable GIST who are treatment naïve (first line therapy) and refused or are ineligible for other standard of care (SOC) therapies. |
| (Phase 1b): Cohort 4 | EXPERIMENTAL | Participants with GIST progression who meet the same criteria as Cohort 2 (third line or greater TKI therapy) and have had prior treatment with investigational agents NB003 or THE-630 or a line of therapy of bezuclastinib plus sunitinib combination. |
| Name | Type | Description |
|---|---|---|
| IDRX-42 | DRUG | IDRX-42 will be administered. |
| Sunitinib | DRUG | Sunitinib will be administered. |
Inclusion Criteria: * Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable. * Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable/metastatic disease. * Documented mutation st...
IDRX-42 is an investigational small molecule being studied for gastrointestinal neoplasms, specifically gastrointestinal stromal tumors (GIST). It is being evaluated in patients with metastatic and/or unresectable GIST and in patients whose disease has progressed after imatinib therapy. It is not yet approved for any use.
IDRX-42 is being developed by GSK plc, which trades under the ticker GSK. The Phase 3 study lists the drug as IDRX-42 (GSK6042981), reflecting GSK's development code for the asset.
IDRX-42 is in Phase 3 development. The Phase 3 trial compares IDRX-42 with sunitinib in patients with gastrointestinal stromal tumors after imatinib therapy. A Phase 1 first-in-human study has also been conducted and is no longer recruiting.
IDRX-42 has two registered trials. NCT07218926 is a recruiting Phase 3 study of IDRX-42 versus sunitinib in GIST after imatinib, enrolling 450 participants across 19 countries. NCT05489237 is a Phase 1 first-in-human study in metastatic and/or unresectable GIST that is active but not recruiting, with 276 participants.
No. IDRX-42 is investigational and remains in clinical development, currently in Phase 3. It has not been approved for marketing in the United States or elsewhere, and it is available only to participants enrolled in its clinical trials.
The two registered IDRX-42 trials together plan to enroll 726 participants. The Phase 3 study NCT07218926 accounts for 450 of these, and the Phase 1 study NCT05489237 accounts for 276. Both studies enroll adults aged 18 years and older.